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Acufex Endobutton Tape
Acufex Microsurgical
Summary: The Acufex Endobutton Tape is a device used primarily in anterior cruciate ligament (ACL) reconstruction. Key evidence highlights its effectiveness in securing grafts with minimal motion and acceptable outcomes in terms of knee stability.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K952535 ↗
Decision Date ?
February 8, 1996
Product Code ?
GAT
Device Class ?
Class 2
Evidence ?
0 studies
The Acufex Endobutton Tape was cleared through the FDA 510(k) pathway on February 8, 1996. It is manufactured by Acufex Microsurgical and classified as a Class 2 device.
What It Is
The Acufex Endobutton Tape is a fixation device used in orthopedic surgeries, particularly for securing soft-tissue grafts in ACL reconstruction. It employs a titanium button and polyester tape mechanism to stabilize grafts within bone tunnels.
FDA-Cleared Indications
- Fixation of soft-tissue grafts during ligament reconstruction procedures.
- Femoral fixation of soft-tissue grafts in anterior cruciate ligament reconstruction.
Clinical Applications
- Securing a soft-tissue graft during ACL reconstruction.
- Fixing the femoral end of an ACL graft at the femoral bone tunnel.
- Maintaining graft fixation while the reconstructed ligament heals to bone.
Reported off-label uses
- Use in other ligament reconstruction procedures, such as selected knee or shoulder ligament repairs, may be reported for similar cortical-button fixation devices but should not be assumed to be covered by this device's FDA labeling.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes two peer-reviewed studies focusing on the use of the Acufex Endobutton Tape in ACL reconstruction. These studies, published between 1999 and 2003, include retrospective analyses and clinical evaluations.
Reported Outcomes
Published studies report that the Acufex Endobutton Tape provides effective graft fixation with minimal graft-tunnel motion. One study noted that 66% of patients achieved normal or nearly normal IKDC scores, with significant improvements in anterior knee stability.
Safety Profile
Reported complications include bone tunnel enlargement, particularly in femoral tunnels, observed in 72% of cases. No other significant adverse events were highlighted in the available studies.
Evidence Limitations
The evidence is limited to a small number of studies with relatively small sample sizes. Further research is needed to evaluate long-term outcomes and compare the device's performance against alternative fixation methods.
Practical Considerations
- The device is intended for use with compatible soft-tissue grafts and bone-tunnel techniques; the surgeon must select the appropriate tape length and button configuration for the anatomy.
- Correct sizing, tunnel placement, graft tensioning and button deployment are important to prevent inadequate fixation, graft motion or soft-tissue irritation.
- The titanium button is generally considered MR Conditional, but MRI conditions should be confirmed from the device labeling and implant records before scanning.
- Potential complications include fixation failure, graft slippage, tunnel widening, infection, pain, stiffness and the usual risks of ligament reconstruction surgery.
- It is a single-use orthopedic implant and should not be reused or resterilized unless the current labeling specifically permits it.
Frequently Asked Questions
What are the clinical indications for Acufex Endobutton Tape?
The device is indicated for use in ACL reconstruction to secure soft-tissue grafts within bone tunnels.
What outcomes have been reported in clinical studies?
Studies report effective graft fixation with 66% of patients achieving normal or nearly normal IKDC scores and improved knee stability.
What complications have been reported?
Safety data indicate bone tunnel enlargement in 72% of femoral tunnels, with no other major complications reported.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.